Protease inhibitor) and elbasvir (NS5A replication complex inhibitor).Īs part of Merck’s broad clinical trials program, grazoprevir/elbasvir Single-tablet combination therapy consisting of grazoprevir (NS3/4A Grazoprevir/elbasvir is Merck’s investigational, once-daily, In combination, to treat a serious or life-threatening disease orĬondition when preliminary clinical evidence indicates that the drug mayĭemonstrate substantial improvement over existing therapies on one or Breakthrough Therapy designation is intended to expedite theĭevelopment and review of a candidate that is planned for use, alone or Grazoprevir/elbasvir for the treatment of patients infected with chronic Hemodialysis, and Breakthrough Therapy designation status for Patients infected with chronic HCV GT1 with end stage renal disease on FDA granted Breakthrough Therapyĭesignation status for grazoprevir/elbasvir for the treatment of
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Submitting additional license applications in other markets by the end Food and Drug Administration (FDA) in May 2015įor the treatment of chronic HCV GT1, 4 or 6 infection, and is The company submitted a New Drug Application for grazoprevir/elbasvir With cirrhosis or certain co-morbidities (i.e., HIV co-infection, Including patient populations who were previously treated, and those Collectively, these trialsĮvaluated treatment regimens in multiple genotypes (GT1, 3, 4 and 6), Grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in The MAA for grazoprevir/elbasvir (100mg/50mg) is based in part upon dataįrom the pivotal C-EDGE clinical trials program, as well as the C-SURFER,Ĭ-SALVAGE and C-SWIFT clinical trials, evaluating Products for Human Use (CHMP) will continue to evaluate the acceleratedĪssessment status throughout the MAA evaluation process. To unmet medical needs or represent a significant improvement overĬurrent treatment options within a major public health interest, such as The EMA’s accelerated assessment is available for products that respond Working with regulatory authorities as we advance grazoprevir/elbasvirįor appropriate patients living with chronic hepatitis C around the
Roy Baynes, senior vice president ofĬlinical development, Merck Research Laboratories. Hepatitis C, including the estimated 15 million people living with theĭisease in Europe, it is important to provide patients and physicians
“Given the diversity of patient populations affected by chronic The EMA will initiate review of the MAA under accelerated assessment With chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection. Single-tablet combination therapy for the treatment of adult patients Grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, Review a marketing authorization application (MAA) for Today announced the European Medicines Agency (EMA) has accepted for KENILWORTH, N.J.–( BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
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